Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-05 @ 11:54 AM
Study NCT ID:
NCT05174767
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2021-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PERSEVERE- a Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000784', 'term': 'Aortic Dissection'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Primary Cohort (n=93) and Continued Access (n=40)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-12-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint to Assess Incidence of Major Adverse Events', 'timeFrame': 'Through 30 days', 'description': 'Patients experiencing at least one of the following MAEs:\n\n1. All-cause mortality (ACM)\n2. New disabling stroke\n3. New onset renal failure requiring dialysis\n4. Myocardial infarction (MI)'}, {'measure': 'Primary Endpoint to Assess Distal Anastomotic New Entry (DANE) tears', 'timeFrame': 'Through 30 days', 'description': 'Patients experiencing Distal Anastomotic New Entry (DANE) tears'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Aortic Diseases', 'Cardiovascular Diseases', 'Aortic Dissection', 'Aortic Remodeling', 'Malperfusion', 'Acute', 'Acute Aortic Dissection'], 'conditions': ['Acute Aortic Dissection']}, 'referencesModule': {'references': [{'pmid': '39116932', 'type': 'BACKGROUND', 'citation': 'Szeto WY, Fukuhara S, Fleischman F, Sultan I, Brinkman W, Arnaoutakis G, Takayama H, Eudailey K, Brinster D, Jassar A, DeRose J, Brown C, Farrington W, Moon MC. A novel hybrid prosthesis for open repair of acute DeBakey type I dissection with malperfusion: Early results from the PERSEVERE trial. J Thorac Cardiovasc Surg. 2025 Jul;170(1):114-123.e3. doi: 10.1016/j.jtcvs.2024.07.059. Epub 2024 Aug 6.'}, {'pmid': '40586922', 'type': 'DERIVED', 'citation': 'Brinkman W, Squiers JJ, Jassar A, Fukuhara S, Fleischman F, Takayama H, Sultan I, Arnaoutakis G, Moon MC, Szeto WY; PERSEVERE Investigators. Cerebral malperfusion resolution after repair of acute DeBakey type I dissection with a novel hybrid prosthesis: early results of the PERSEVERE Studydagger. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf199. doi: 10.1093/ejcts/ezaf199.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, non-randomized, multicenter clinical investigation to assess the safety and effectiveness of AMDS in the treatment of patients with acute DeBakey type I dissection, with evidence of malperfusion, through open surgical repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age or ≤80 years of age (male or female) at time of surgery\n* Acute DeBakey type I dissection based on computed tomography angiography (CTA) and diagnosed ≤14 days from of the index event\n* Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)\n\nExclusion Criteria:\n\n* Other medical condition that is associated with limited life expectancy \\<2 years (e.g., cancer, congestive heart failure)\n* Pregnant or breastfeeding.\n* Unwilling to comply with the follow-up schedule\n* Institutionalized due to administrative or judicial order\n* Unwilling to accept blood transfusions for any reason\n* Coronary malperfusion\n* In circulatory shock (i.e., systolic blood pressure \\<90 mmHg) at time of screening\n* In extreme hemodynamic compromise requiring cardiopulmonary resuscitation at time of screening\n* Suspicion of bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, low pH, and/or acidosis)\n* Clinical or radiographic signs of bowel infarction or gastrointestinal hemorrhage\n* Base deficit \\> -10 mmol/L or -10 mEq/L\n* American Society of Anesthesiologists risk class V (i.e., moribund patient not expected to live 24 hours with or without operation) or class VI (a declared brain dead patient whose organs are being removed for donor purposes)\n* Previous placement of a thoracic endovascular graft\n* Interventional and/or open surgical procedures 30 days prior to the dissection repair\n* Planned major interventional and/or open surgical procedures 30 days post the dissection repair\n* Systemic infection\n* Uncontrollable anaphylaxis to iodinated contrast (patients with allergy to iodinated contrast but not anaphylaxis may be eligible with appropriate pre-medication, as deemed suitable by the Investigator)\n* Known allergy(ies) to nitinol and/or polytetrafluoroethylene\n* Inability to obtain CT angiograms for follow-up\n* Previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, or Loeys-Dietz syndrome based on laboratory genetic testing\n* Diagnosed with acute myocardial infarction in the 30 days prior to the dissection diagnosis\n* Diagnosed with severe and catastrophic neurological complications in the 30 days prior to the dissection diagnosis (namely, obtundation or coma)\n* Current Stage 5 end stage chronic kidney disease (eGFR ≤ 15 mL/min)\n* History of bleeding disorder (i.e. hemophilia)\n* A primary entry tear that extends into the arch or distal to the left subclavian artery\n* Need for a total aortic arch replacement and/or repair, or reconstruction, of any part of the arch, and branch vessels (including extra-anatomic bypass of the branch vessels), for any reason as deemed necessary by the Investigator\n* Any pathology of mycotic origin\n* Aortic fistulous communication with non-vascular structure (e.g., esophagus, bronchial)\n* Extensive thrombus or calcifications in the aortic arch, as defined by CTA\n* Excessive tortuosity precluding safe passage of the AMDS, as defined by CTA\n* Descending thoracic aneurysm involving the proximal third (one-third) of the descending aorta and measuring \\>45 mm in diameter\n* Aortic arch aneurysm \\>50 mm in diameter'}, 'identificationModule': {'nctId': 'NCT05174767', 'acronym': 'PERSEVERE', 'briefTitle': 'PERSEVERE- a Trial to Evaluate AMDS in Acute DeBakey Type I Dissection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Artivion Inc.'}, 'officialTitle': 'A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE', 'orgStudyIdInfo': {'id': 'AMDS2101.000-C (02/21)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute DeBakey Type I Dissection', 'description': 'In eligible patients, the ascending aorta is transected and removed in a routine standard of care manner utilizing hypothermic circulatory arrest; the operator will leave at least 10 mm (1.0 cm) aortic tissue proximal to the innominate artery. AMDS is pre-loaded onto the delivery system and is delivered into the true lumen through the open distal aorta and implanted according to the instructions for use.', 'interventionNames': ['Device: AMDS']}], 'interventions': [{'name': 'AMDS', 'type': 'DEVICE', 'description': 'AMDS Implantation', 'armGroupLabels': ['Acute DeBakey Type I Dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94035', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Medical Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center/New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Einstein Medical', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau Medical Center', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Ascension Seton/University of Texas', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Baylor College of Medicine/ St. Luke's Medical Center", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White The Heart Hospital Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Wilson Szeto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Artivion Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}